Synthes Rapid Resorbable Orbital Floor Plate Recalled for Labeling Errors
Synthes (USA) Products LLC is recalling 19 units of 1.5 mm Rapid Resorbable Orbital Floor Plates due to potential expiration date discrepancies on outer packaging labels.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and involves a labeling error regarding expiration dates, which fits the rubric criteria for moderate severity involving minor labeling errors or low-risk contamination.
Plain-English summary
Synthes (USA) Products LLC is recalling 19 units of the 1.5 mm Rapid Resorbable Orbital Floor Plate with Bending Template. The product is a sterile, rapid resorbable fixation system intended for fracture repair and reconstructive procedures of the craniofacial skeleton in pediatric and adult populations.
The recall was initiated due to labeling errors where the expiration date on the outer package label may exceed the expiration date of the subcomponents. The affected units are identified by Catalog # 851.690.01S and Lot # 6904416, 6904418, or 7672126.
The products were distributed nationwide to facilities in Delaware, North Carolina, California, Oklahoma, Pennsylvania, South Carolina, Wisconsin, Colorado, New Jersey, Texas, Utah, Illinois, Missouri, Michigan, Alabama, and Kansas. Healthcare providers and facilities should stop using the affected units and contact Synthes (USA) Products LLC for instructions on return or replacement.
The recalled product
- Product
- 1.5 mm Rapid Resorb Orbt1 F1 P1 w/Bending Template / 30 mm - Sterile, Rapid Resorbable Fixation System. 1.5 mm Rapid Resorbable Orbital Floor Plate with Bending Template. Intended for use in fracture repair and reconstructive procedures of the craniofacial skeleton in pediatr
- Manufacturer
- Synthes (USA) Products LLC
- Hazard
- Affected units
- 19
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Catalog # 851.690.01S
- Lot # 6904416
- 6904418
- 7672126
Distribution
Part of a larger recall action
This product is one of 3 recalled by Synthes (USA) Products LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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